Effect of Sitagliptin on Progression of Coronary Intermediate Lesion

Li Bo120 enrolled

Overview

This study was to investigate the Effect of Sitagliptin, a dipeptidyl peptidase-4 inhibitor, on Progression of Coronary Intermediate Lesion.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

120

Conditions

Atherosclerosis Type 2 Diabetes Mellitus

Interventions

SitagliptinDRUG

5 mg, 1 tablet per day for 12 months

PlaceboDRUG

Placebo,1 tablet per day for 12 months

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients \> 18, \< 80 years old, with type 2 diabetes mellitus and angiographically proven Coronary Intermediate Lesion. Exclusion Criteria: * Allergy or hypersensitivity to any of the drug's components. * Severe liver failure, moderate or severe kidney failure * Malignant disease. * Active infectious disease. * Pregnancy or breastfeeding.

Locations (1)

The General Hospital of PLA

Beijing, Beijing Municipality, China

Outcomes

Primary Outcomes

Changes in late lumen loss of target lesion

A coronary intermediate lesion in Patients with coronary heart disease complicated with Type 2 Diabetes was measure with 3D QCA(3D Quantitative Coronary Angiography). To measure the changes in target lumen at 12 months.

Time frame: Changes from baseline in late lumen loss of target lesion at 12 months

Secondary Outcomes

Incidence rate of MACE

MACE include composite of death, myocardial infarction, or target-vessel revascularization.

Time frame: Incidence rate of MACE from baseline to 12 months

Data from ClinicalTrials.gov

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